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Clinical Trial
. 2025 Nov;26(7):541-551.
doi: 10.1016/j.cllc.2025.07.003. Epub 2025 Jul 9.

The Italian Mauris Phase IIIb Trial of Atezolizumab Plus Carboplatin and Etoposide for Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer: 3-Year End-of-Study Results

Floriana Morgillo  1 , Ester Del Signore  2 , Emilio Bria  3 , Filippo de Marinis  4 , Fortunato Ciardiello  5 , Marina Chiara Garassino  6 , Alessio Stefani  7 , Francesco Verderame  8 , Alessandro Morabito  9 , Andrea Sbrana  10 , Giuseppe Tonini  11 , Marina Gilli  12 , Rossana Berardi  13 , Paola Adriana Taveggia  14 , Alessandra Bearz  15 , Angelo Delmonte  16 , Maria Rita Migliorino  17 , Cesare Gridelli  18 , Giovanni Maria Fadda  19 , Manuela Iero  20 , Andrea Ardizzoni  21
Affiliations
Free article
Clinical Trial

The Italian Mauris Phase IIIb Trial of Atezolizumab Plus Carboplatin and Etoposide for Patients With Newly Diagnosed Extensive-Stage Small Cell Lung Cancer: 3-Year End-of-Study Results

Floriana Morgillo et al. Clin Lung Cancer. 2025 Nov.
Free article

Abstract

Background: Atezolizumab combined to carboplatin and etoposide prolonged survival in the IMpower133 trial of untreated extensive-stage small-cell lung cancer (ES-SCLC). Aim of this analysis is to provide end-of-study results from the phase IIIb MAURIS study on the efficacy and safety of atezolizumab plus chemotherapy in the same disease setting, in a patient population with broader inclusion criteria.

Materials and methods: MAURIS is a multicentric, open-label, single-arm study conducted between 2019 and 2023 in 25 Italian study centres. A total of 155 patients with untreated ES-SCLC were enrolled. Treatment was based on atezolizumab 1200 mg + carboplatin + etoposide every 21 days, for 4 to 6 cycles, during the induction phase, and atezolizumab every 3 weeks during the maintenance phase. Safety, overall survival (OS) and progression-free survival (PFS) were among study endpoints.

Results: The median OS at end of study was 10.6 months, with OS rates of 45.5% at 1 year, 31.0% at 1.5 years, 17.1% at 2 years and 14.5% at 3 years. The median PFS was 5.5 months. Serious adverse events (AEs) occurred in 38.3% of patients, treatment-related serious AEs in 21.4%, and immuno-mediated treatment-emergent AEs in 26.6% of patients. Immune-mediated grade 3 to 4 AEs were inversely related with mortality (hazard ratio, HR = 0.36; 95% confidence interval, CI: 0.13-0.97) in a multivariate analysis.

Conclusion: This study showed consistent findings with the IMpower133 trial on the safety and efficacy of atezolizumab plus chemotherapy in first-line treatment of ES-SCLC. Long-term survival of a subgroup of patients was also confirmed.

Keywords: Extended stage; Immunotherapy; Overall survival; Safety; Survival.

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Conflict of interest statement

Disclosure Prof. Ardizzoni has received honoraria for lectures from BMS, Astra Zeneca, MSD and has been member of the Advisory Board of Roche, Astra Zeneca, BMS, Sanofi and Eli Lilly. Dr. Bearz has received consulting fees from Pfizer and honoraria for lectures from Pfizer, MSD, Roche and Astra Zeneca and has been a member of the Advisory Board of Lilly, Astra Zeneca, Pfizer and Roche. Prof. Berardi has received grants or contracts, consulting fees, payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AZ, Boeringher, MSD, Lilly, Roche, Amgen, GSK, Eisai and BMS; she has been member of Data Safety Monitoring Board or Advisory Board of AZ, Boeringher, MSD, Lilly, Roche, Amgen, GSK, Eisai, BMS and Expert member of AIFA Oncological Team Board, President of FONICAP, Member of AIOM National Council Board, President LOTO ODV Scientific Committee; she had a Leadership or fiduciary role in AZ, Boeringher, MSD, Lilly, Roche, Amgen, GSK, Eisai and BMS. Prof. Bria has received grants or contracts from Italian Association for Cancer Research, Università Cattolica del Sacro Cuore, Italian Ministry of Health, Astra-Zeneca, Roche and honoraria for lectures from Merck-Sharp and Dome, Astra-Zeneca, Pfizer, Eli-Lilly, Bristol-Myers Squibb, Novartis and Roche; he has been member of Data Safety Monitoring Board or Advisory Board of Merck-Sharp and Dome, Pfizer, Novartis, Bristol-Myers Squibb, Astra-Zeneca, and Roche. Prof. Ciardiello has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Merck, MSD, Servier, Pierre Fabre and has been member of Data Safety Monitoring Board or Advisory Board of MSD, Pierre Fabre, Servier, Merck, Roche, Pfizer. Prof. De Marinis has received payment or honoraria for speakers’ bureaus from Roche, Astrazeneca, BMS, Novartis, Merck and has been a member of the Advisory Board of Roche, AZ, BMS, Novartis, Merck. Dr. Del Signore has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Roche. Dr. Delmonte has received support for attending meetings and/or travel from MSD, Roche, Takeda and has been a member of Data Safety Monitoring Board or Advisory Board of Novartis, Pfizer, Immunocore. Prof. Garassino has received consulting fees from AstraZeneca, MSD International GmbH, Bayer, BMS, Boehringer Ingelheim Italia S.p.A, Celgene, Eli Lilly, Incyte, Novartis, Pfizer, Roche, Takeda, Seattle Genetics, Mirati, Daiichi Sankyo, Regeneron, Merck, Blueprint, Jansenn, Sanofi, AbbVie, BeiGenius and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from AstraZeneca, MSD International GmbH, Merck, Celgene, Eli Lilly, Incyte, Roche. Dr. Gridelli has received consulting fees from Menarini, Roche and payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Roche, Astra Zeneca, MSD, BMS, Amgen, Pfizer, GSK, Takeda, Kyriopharm, Sanofi, Boehringer, Eli Lilly; he has been member of Data Safety Monitoring Board or Advisory Board of Roche, Astra Zeneca, MSD, BMS, Amgen, Pfizer, GSK, Takeda, Kyriopharm, Sanofi, Boehringer, Eli Lilly. Dr. Iero is an employee of Roche Farma Spa. Dr. Migliorino has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Roche, Astra Zeneca, Pfizer, Sanofi, Novartis, Eli Lilly and support for attending meetings and/or travel from Novartis, Sanofi, Takeda. Dr. Morabito has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from Roche, BMS, AstraZeneca, MSD, Novartis, Takeda, Lilly, Pfizer, Boehringer and he has been member of Data Safety Monitoring Board or Advisory Board of AstraZeneca, Takeda, Pfizer, MSD. Prof. Morgillo has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from MSD International GmbH, BMS, Boehringer, Ingelheim Italia S.p.A, Roche and support for attending meetings and/or travel from MSD. Dr. Tonini has been a member of the Advisory Board of Molteni, Novartis, MSD, Pharmamar. Prof. Verderame has received grants or contracts from Roche, Astra Zeneca, GSK, MSD, Janssen, Servier, Takeda and support for attending meetings and/or travel from Janssen, Roche, MSD. Dr. Fadda, Dr. Gilli, Dr. Stefani, Dr. Sbrana, Dr. Taveggia declare no potential competing interests.

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